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Nucleoside Analog

CPX-351 vs CLAG-M for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Roland Walter

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of untreated "high-grade" myeloid neoplasm (>=10% blasts in blood or bone marrow) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification. Outside diagnostic material is acceptable to establish diagnosis; submission of peripheral blood specimen for flow cytometry performed at the study institution should be considered. Diagnostic material must have been submitted for cytogenetic and/or molecular testing as clinically appropriate

Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model

Must not have

Concomitant illness associated with a likely survival of < 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying CPX-351 or the CLAG-M regimen to see how well they work in treating patients with acute myeloid leukemia or other high-grade myeloid neoplasms who are not physically fit enough for standard doses of CPX-351.

Who is the study for?

This trial is for less-fit patients with untreated high-grade myeloid neoplasms or AML, excluding acute promyelocytic leukemia. Participants must have a specific risk score (TRM >= 13.1), agree to use contraception, and be able to consent. Prior low-intensity treatments are allowed; significant liver function and heart health are required.

What is being tested?

The study compares CPX-351 chemotherapy against the CLAG-M regimen in treating medically less-fit patients with certain types of blood cancer. It aims to determine if full doses used for fitter patients could be more effective than reduced doses in this population.

What are the potential side effects?

Chemotherapy drugs like CPX-351 and those in the CLAG-M regimen can cause side effects such as nausea, fatigue, increased infection risk due to lowered white blood cell counts, hair loss, mouth sores, and potential damage to organs like the heart or liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of untreated high-grade blood cancer, not including APL.

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My treatment risk score is 13.1 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health condition that may reduce my life expectancy to less than a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3-month overall survival (OS)

Secondary study objectives

Complete remission (CR) rates

Incidence of adverse events

MRDneg CR rates

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (CLAG-M)Experimental Treatment6 Interventions

INDUCTION: Patients receive cladribine IV over 2 hours on days 1-5, cytarabine IV over 2 hours on days 1-5, G-CSF SC on days 0-5, and mitoxantrone IV over 60 minutes on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response other than an MRDneg CR receive a second course of cladribine IV over 2 hours on days 1-5, cytarabine IV over 2 hours on days 1-5, G-CSF SC on days 0-5, and mitoxantrone IV over 60 minutes on days 1-3 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients who achieve a CR/CRi receive an intermediate dose of cytarabine IV over 2 hours on days 1-6 for up to 4 additional courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (CPX-351)Experimental Treatment3 Interventions

INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response other than an MRDneg CR receive a second course of CPX-351 intravenously IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients who achieve a CR/CRi receive a reduced dose of CPX-351 IV over 90 minutes on days 1, 3, and 5 for up to 4 additional courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3330

Mitoxantrone

2008

Completed Phase 3

~1550